[0003] Currently there are many drugs for treating hyperlipidemia, such as application number: 94107184.7, application date: 94.6.14, applicant: Military
Medical Research Institute of the Logistics Department of the Lanzhou Military Region of the Chinese People's Liberation Army, and the name of the invention: the formula of Suanzaoren Oil Jiangzhi Dropping Pills The invention provides a
traditional Chinese medicine for treating hyperlipidemia, wherein the
medicine uses
polyethylene glycol and other auxiliary materials to make
jujube seed oil into drop pills, and the auxiliary materials used in the drop pills are not highly natural
[0004] With the global expansion of the market and the requirement of human beings to return to nature, the use of drugs with
low toxicity and side effects, especially pure natural drugs, has become the first choice of people. The preparation is a kind of high-efficiency, quick-acting new Chinese medicine preparation, which overcomes the shortcomings and deficiencies of the previous Chinese medicine preparations, but the current drop
pill preparations generally face the following problems: 1. The natural degree of drop
pill auxiliary materials is not high: at present, the drop pill matrix Most of the excipients are chemical synthetic products with a low degree of naturalness. It is very difficult to find new alternative matrix excipients, especially the search for alternative matrix excipients with a high degree of naturalness and the determination of their preparation process, because currently common and possible The preparation conditions required for the substitutes of natural matrix excipients are very harsh, and the temperature of excipients and the droplet dripping conditions are the
key factors affecting the preparation of droplet pills
2. Problems encountered in the export of dripping pills: With the development of the economy, the market is becoming more and more internationalized, and China is also trying to adapt to this trend. Currently, Chinese medicine dripping pills, which are used as
health food, have been successfully exported to many countries, but There are also many problems at present, because different countries have different approvals for the excipients selected for the preparation of Chinese medicine dripping pills, especially in Europe with developed industries, which have stricter regulations on food excipients and pharmaceutical excipients, and the drops exported as
health food The chemically synthesized auxiliary materials (such as
polyethylene glycol) selected for pill preparations are not listed in the
food additive catalogs of some countries, which is very unfavorable for Chinese medicine dripping pill preparations to enter the
international market, and has become a stumbling block for Chinese medicine to enter the
international market. Therefore, looking for One or more new matrix excipients that can be accepted by the
international market are particularly important and urgent
3. Disadvantages of
mouthfeel and speed of
onset of action: Poor taste of
traditional Chinese medicine and its preparations is one of its major characteristics. When people take certain medicines, they are far more afraid of the bad taste of the medicine than they are of the
disease. What's more, some patients give up the treatment of
traditional Chinese medicine because they can't overcome the bad taste or smell of traditional Chinese medicine or its preparations. For example, making the medicine into capsules or
sugar-
coated tablets can improve the taste and reduce stimulation, but the disintegration speed is prolonged. , which is not conducive to the
rapid onset of the
drug, and is not suitable for some diseases, especially those that require the
rapid onset of the
drug4. Difficult preparation process for industrial production of dripping pills: In the replacement process of dripping pill preparation auxiliary materials, it is very difficult to determine the preparation process for industrial production, such as the
melting temperature of matrix auxiliary materials, dripping temperature, auxiliary materials and The ratio of the
drug, the ratio of the
caliber of the dropper, and the condensing agent are all factors that affect the drop pills. Therefore, it is time-consuming and expensive to replace the matrix and be suitable for industrial production.
[0005] In order to change the long-term situation that the base auxiliary materials of dropping pills are mainly chemically synthesized auxiliary materials, solve the problem that the base of dropping pills is currently facing a low degree of naturalness, which is increasingly unable to satisfy people. It is required to return to nature, take the problem of pure
natural medicine with
low toxicity and no side effects; it can also solve some problems encountered in the export process of Chinese medicine preparations, especially dripping pill preparations, and enhance the competitiveness of the international market; A large number of experiments and research on preparation technology have invented a pure Chinese medicine dripping pill preparation with low toxic and side effects, significant
curative effect, moderate price and suitable for industrialized large-scale production.